A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration (PAVE)

January 10, 2020 updated by: Santen Inc.

A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
      • Walnut Creek, California, United States, 94598
    • Michigan
      • Jackson, Michigan, United States, 49202
    • Texas
      • Austin, Texas, United States, 78705
      • McAllen, Texas, United States, 78503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide signed written informed consent
  • Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
  • Prior treatment in the study eye with any intravitreal anti-VEGF medication
  • At least one lesion in the study eye that meets minimal pathology criteria
  • Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
  • Best corrected visual acuity of 20/200 or better in the fellow eye
  • Reasonably clear media and some fixation in the study eye

Exclusion Criteria:

Ocular

  • Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
  • Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
  • Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
  • Need for ocular surgery in the study eye during the course of the study
  • Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results

Non-Ocular

  • Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
  • Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
  • Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
  • Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
  • Unable to comply with study procedures or follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose DE-122
Single intravitreal injection of DE-122 Low Dose Injectable Solution
Drug: 0.5 mg of DE-122
DE-122 Injectable Solution
Experimental: Medium-Low Dose DE-122
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
Drug: 1.0 mg of DE-122
DE-122 Injectable Solution
Experimental: Medium-High Dose DE-122
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
Drug: 2.0 mg of DE-122
DE-122 Injectable Solution
Experimental: High Dose DE-122
Single intravitreal injection of DE-122 High Dose Injectable Solution
Drug: 4.0 mg of DE-122
DE-122 Injectable Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
Time Frame: Baseline (Day1) and Day 90.

BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters.

An increase in BCVA indicates an improvement in the best corrected vision.
Baseline (Day1) and Day 90.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Time Frame: Baseline (Day1) and Day 90.
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Baseline (Day1) and Day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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